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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02912910
Other study ID # 27464
Secondary ID
Status Withdrawn
Phase N/A
First received September 12, 2016
Last updated November 8, 2017
Start date September 2016
Est. completion date January 2017

Study information

Verified date November 2017
Source St. Louis University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To study central blood pressure changes caused by commonly used high blood pressure medications in pregnancy.


Description:

Central blood pressures in addition to pulse wave velocity will be attained prior to medication, and then every 30 minutes for 4 hours (total of 9 readings). Sphygmomanometer readings will be completed at the same time (total readings 9). These readings are all related to the study.

Nursing will have the opportunity to to record the routine sphygmomanometer readings for their routine vitals if they chose to do so.

Their participation will be complete after the 4 hour assessment is complete.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 14 Years to 50 Years
Eligibility Inclusion Criteria:

- Singleton pregnancy

- Women with hypertensive disease in pregnancy who are currently being treated with nifedipine xl or labetalol

Exclusion Criteria:

- Multiple pregnancy

- Currently on multiple anti-hypertension medications

- Narcotic use

- Irregular heart rhythms or arrhythmias

- Peripheral arterial disease, leg artery disease

- Reynaud's phenomena

- Intense cold/hypothermia

- If there is a wound at location of where central arterial cuff would be placed or tonometer for carotid assessment

- Known sensitivity to labetalol or nifedipine

- Severe tachycardia (>120)

- Greater than 1st degree heart block

- Severe asthma

- Congestive heart failure or heart disease

- Lupus

- Inability to adequately monitor BP

- Currently receiving magnesium sulfate

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Nifedipine
patients will be assigned to antihypertensive medications by their physicians in the course of their routine care
Labetalol
patients will be assigned to antihypertensive medications by their physicians in the course of their routine care

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
St. Louis University

Outcome

Type Measure Description Time frame Safety issue
Primary central blood pressure changes every 30 min for 4 hours
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